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U.S. Department of Health and Human Services

Class 2 Device Recall Best Practices kits containing certain production lots of Clearify Visualization System

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  Class 2 Device Recall Best Practices kits containing certain production lots of Clearify Visualization System see related information
Date Initiated by Firm October 04, 2016
Create Date December 22, 2016
Recall Status1 Terminated 3 on August 08, 2018
Recall Number Z-0890-2017
Recall Event ID 75301
510(K)Number K062779  
Product Classification Instrument, special lens, for endoscope - Product Code FEI
Product Best Practices kits containing certain production lots of Clearify Visualization System
Item Code: 21-345
Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Code Information Kit Parent Codes: 00Z2224 00Z2232 00Z2298 00Z2363  00Z2364  00Z2365 00Z2366  00Z2421  00Z2425 00Z2430  00Z2431  00Z2460 00Z2493  00Z2534  00Z2535  000Z2544  00Z5000B  00Z5001B  GYNKIT2          
Recalling Firm/
Manufacturer		 Medtronic
60 Middletown Ave
North Haven CT 06473-3908
Manufacturer Reason
for Recall		 Product sterility is compromised due to breach of the sterile barrier
FDA Determined
Cause 2		 Employee error
Action Covidien issued an Urgent Medical Device Recall letter on October 4, 2016 and a corrected letter on October 10, 2016 to US Customers via Federal Express. The letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Disposition of product within Medtronic control and customer returned devices will be reworked. Questions or concerns, contact your Medtronic representative or customer service at 800-882-5878.
Quantity in Commerce 230 systems
Distribution Worldwide Distribution - US (Nationwide) Foreign: Austria Belgium Bulgaria Brazil Chile Cyprus Denmark Egypt Finland France France Germany Greece Hungary Iran Ireland Israel Italy Japan Kenya Kuwait Latvia Luxembourg Mexico Namibia Netherlands Nigeria Norway Poland Portugal Romania Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FEI and Original Applicant = NEW WAVE SURGICAL CORPORATION
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